Marco Bügel

m.buegelnoSpam@axxos.noSpamch

 

  • SAQ-qualified quality expert medical device field
  • Qualified environmental systems manager- ISO 14001
  • Chemical lab technician, subject area analytics
  • IRCA certified lead auditor ISO 13485:2016

Senior Consultant at Axxos GmbH since 2015

Experience

  • >10 years in medical device industry
  • Head of quality management in medical engineering, metal and cosmetics industry
  • Establishment and management of a testing lab for polymer technology
  • Optimisation of equipment, processes and methods

Projects

  • Installing, running and optimising of quality management systems ISO 9001 + ISO 13485
  • Key position in developing medical devices of classes I, IIa + IIb
  • Experience in medical device field, especially in dental (composites) and orthopedics (spine & trauma)
  • Process optimization in polymer-, coating- and cleaning techniques in polymer and metal industry
  • Implementation and evaluation of CAQ systems
  • Implementation of CAQ software (Babteq)
  • CAPA management
  • Planning and executing of trainings in hygiene and concepts

Skills

  • Medical device field
  • Polymer technology (thermoplasts, impact extrusion)
  • Damage and failure analysis polymer parts
  • Metal industry (processing of aluminium, impact extrusion)
  • Planning and optimising manufacturing and cleaning processes
  • Audit according to ISO 9001, ISO 13485, ISO 14001
  • Clean room monitoring 

My personal Scrabble